# FDA 483 - Product Design and Development Corp. - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/product-design-and-development-corp/91276afc-e93f-4bde-8f47-844795054c95

> FDA 483 for Product Design and Development Corp. on January 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Product Design and Development Corp.
- Inspection Date: 2025-01-24
- Product Type: device
- Office Name: Kansas City District Office
- Summary: Product Design and Development Corp. in Ellisville, MO, was inspected by the FDA, revealing significant deficiencies in their medical device manufacturing processes. Observations included the failure to apply unique device identifiers (UDI) to medical device labels and packaging, inadequate maintenance of device history records, and a lack of documented personnel training for critical assembly tasks. These issues indicate a need for improved quality system controls, with some observations being repeats from previous inspections.

## Related Documents

- [483 - 2022-03-17](https://www.globalkeysolutions.net/records/483/product-design-and-development-corp/ef1bd49d-a601-4d00-8f6e-3b0c8be37e42)

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/product-design-and-development-corp/7159aa80-c032-42e7-a2f8-4e907c4bfe0c

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79